C4591001_Clinical_Protocol.pdf
Moderna and Pfizer show their work
In an unprecedented show of transparency, the two frontrunners in the race to develop a Covid-19 vaccine released detailed protocols describing the studies testing their vaccines. The unusual step is part of an effort to proactively increase the public's trust in an eventual vaccine.
"This is an example of the comprehensive trial description that industry should be sharing," said Harlan Krumholz, a Yale cardiologist who has been a long-time advocate for increased transparency from drug companies.
The protocols are dense, and researchers will be poring over them in coming days. In both cases, there are plans for potentially stopping the studies early if the vaccines prove more effective than planned. Both protocols require that decision to be suggested by an independent Data Monitoring Committee, not by the companies. And in both cases, this committee reports directly to the company, not to academics who are running the study, something some experts say is disappointing. The Moderna protocol can be found here, and the Pfizer one here.
"This is an example of the comprehensive trial description that industry should be sharing," said Harlan Krumholz, a Yale cardiologist who has been a long-time advocate for increased transparency from drug companies.
The protocols are dense, and researchers will be poring over them in coming days. In both cases, there are plans for potentially stopping the studies early if the vaccines prove more effective than planned. Both protocols require that decision to be suggested by an independent Data Monitoring Committee, not by the companies. And in both cases, this committee reports directly to the company, not to academics who are running the study, something some experts say is disappointing. The Moderna protocol can be found here, and the Pfizer one here.
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